G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-01-01

Brief Summary

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This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.

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Detailed Description

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Conditions

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Gynecologic Cancer Myelosuppression Adult Febrile Neutropenia Chemotherapy-induced Neutropenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long-acting G-CSF group

Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.

Group Type EXPERIMENTAL

Long-acting G-CSF

Intervention Type DRUG

Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.

Short-acting G-CSF group

Patients in long-acting G-CSF group only accept short-acting G-CSF.

Group Type EXPERIMENTAL

Short-acting G-CSF

Intervention Type DRUG

Short-acting G-CSF will be given as required 24 hours after the chemotherapy.

Interventions

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Long-acting G-CSF

Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.

Intervention Type DRUG

Short-acting G-CSF

Short-acting G-CSF will be given as required 24 hours after the chemotherapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed primary gynecologic cancer
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No immunosuppressive disease

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No